Brief description of study

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics (explores
what the body does to the drug), and anti-mycobacterial activity of bedaquiline (TMC207) in
children and adolescents (0 months to less than [<] 18 years of age) diagnosed with confirmed
or probable pulmonary multidrug resistant tuberculosis (MDR-TB), in combination With a
Background Regimen (BR) of MDR-TB Medications.

Detailed Study Description

This is an open-label (all people know the identity of the intervention), multicenter (when
more than one hospital or medical school team work on a medical research study) and Phase 2
study. The study will consist of a screening phase, a 24-week open-label treatment phase
during which all participants will receive bedaquiline (TMC207) in combination with a BR of
MDR-TB medications, and a 96-week follow-up phase. Upon completion of the 24-week treatment
with bedaquiline, all participants will continue to receive their BR under the care of the
investigator. The total study duration will be 120 weeks for each participant. There will be
4 age based cohorts in this study. Cohort 1: greater than or equal to (>=) 12 to less than
(<) 18 years of age; Cohort 2: >=5 to <12 years of age; Cohort 3: >=2 to <5 years of age;
Cohort 4: 0 months to <2 years of age. Participants in Cohorts 1 and 2 will be enrolled
concurrently followed by sequential enrollment of Cohorts 3 and 4. An internal safety
monitoring group will review safety and pharmacokinetic data from each cohort to determine
subsequent cohort enrollment and dose. Participants' safety will be monitored throughout the
study.